药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/10/29 – 2024/11/04
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 3
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
344filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 94 |
| New drug | 52 |
| Import | 12 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 85 |
| 治疗用生物制品 | 34 |
| Biologic | 6 |
| 预防用生物制品 | 6 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 6 | 3 | 58 |
| 2 | 多索茶碱片 | 4 | 2 | 2 |
| 3 | 磷酸奥司他韦干混悬剂 | 3 | 2 | 2 |
| 4 | 注射用氨苄西林钠舒巴坦钠 | 3 | 1 | 13 |
| 5 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
| 6 | 盐酸甲氧氯普胺注射液 | 2 | 2 | 6 |
| 7 | 盐酸纳美芬注射液 | 2 | 2 | 1 |
| 8 | 门冬氨酸钾镁注射液 | 2 | 2 | 3 |
| 9 | 依折麦布阿托伐他汀钙片 | 2 | 1 | 4 |
| 10 | 奥贝胆酸片 | 2 | 1 | 0 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广东星昊药业有限公司 | 16 | 13 | 0 |
| 2 | 福州海王金象中药制药有限公司 | 16 | 12 | 0 |
| 3 | Novo Nordisk A/S | 11 | 3 | 0 |
| 4 | 陕西康惠制药股份有限公司 | 4 | 4 | 0 |
| 5 | Amgen Inc. | 4 | 2 | 0 |
| 6 | 哈药集团世一堂制药厂 | 3 | 3 | 0 |
| 7 | 河南省百泉制药有限公司 | 3 | 3 | 0 |
| 8 | 石药集团巨石生物制药有限公司 | 3 | 3 | 0 |
| 9 | 西安碑林药业股份有限公司 | 3 | 3 | 0 |
| 10 | 中国医学科学院医学生物学研究所 | 3 | 2 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/04New drug · Class 1.3 | ZY022胶囊CXZL2400076 | 中国医学科学院药物研究所; 湖南省天玑珍稀中药材发展有限公司 |
| 2024/11/04New drug · Class 1.3 | ZY022CXZL2400075 | 中国医学科学院药物研究所; 湖南省天玑珍稀中药材发展有限公司 |
| 2024/11/02Generic · Class 3 | 间苯三酚口崩片CYHS2403744 | 南京海纳制药有限公司 |
| 2024/11/02Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2403743 | 南京易亨制药有限公司 |
| 2024/11/02Generic · Class 3 | 多索茶碱片CYHS2403742 | 浙江花园药业有限公司 |
| 2024/11/02Generic · Class 3 | 多索茶碱片CYHS2403741 | 浙江花园药业有限公司 |
| 2024/11/02Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2403734 | 平光制药股份有限公司 |
| 2024/11/02Generic · Class 3 | 盐酸溴己新口服溶液CYHS2403730 | 江苏开元药业有限公司; 江苏欧歌制药有限公司 |
| 2024/11/02New drug · Class 3.3 | 流感病毒裂解疫苗CXSS2400118 | 安徽智飞龙科马生物制药有限公司 |
| 2024/11/02New drug · Class 1 | 注射用HLX43CXSL2400747 | 上海复宏汉霖生物技术股份有限公司; 上海复宏汉霖生物医药有限公司 |
| 2024/11/02New drug · Class 1 | SYHA1813口服溶液CXHL2401166 | 上海润石医药科技有限公司 |
| 2024/11/02New drug · Class 1 | SYHA1813口服溶液CXHL2401165 | 上海润石医药科技有限公司 |
| 2024/11/02New drug · Class 1 | SYHA1813口服溶液CXHL2401164 | 上海润石医药科技有限公司 |
| 2024/11/02New drug · Class 2.3 | HQ2303CXHL2401163 | 百诚医药(珠海横琴)有限公司 |
| 2024/11/02New drug · Class 1 | 注射用MB0151CXHL2401162 | 主流源生物科技(上海)有限公司; 中山主流源生物科技有限公司 |
| 2024/11/02New drug · Class 2.1;2.4 | 盐酸(R)-氯胺酮注射液CXHL2401161 | 江苏豪森药业集团有限公司 |
| 2024/11/02New drug · Class 1 | SYHX1901片CXHL2401160 | 石药集团欧意药业有限公司 |
| 2024/11/02New drug · Class 2.1;2.4 | 盐酸(R)-氯胺酮注射液CXHL2401159 | 江苏豪森药业集团有限公司 |
| 2024/11/02New drug · Class 1 | SYHX1901片CXHL2401158 | 石药集团欧意药业有限公司 |
| 2024/11/02New drug · Class 2.2 | BN020827HCXHL2401157 | 山东百诺医药股份有限公司 |
| 2024/11/01Import · Class 2.2 | 注射用德曲妥珠单抗JXSL2400211 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/11/01Import · Class 1 | PIT565JXSL2400210 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/01Import · Class 3.1 | 13价肺炎球菌多糖结合疫苗JXSL2400209 | Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd. |
| 2024/11/01Import · Class 2.4 | BMS-986165片JXHL2400262 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/11/01Import · Class 2.4 | BMS-986165片JXHL2400261 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/11/01Import · Class 2.4 | BMS-986165片JXHL2400260 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/11/01Generic · Class 3 | 钠钾镁钙注射用浓溶液CYHS2403726 | 河南上恒医药科技有限公司; 山东方明药业集团股份有限公司 |
| 2024/11/01Generic · Class 3 | 盐酸纳美芬注射液CYHS2403723 | 甘肃农垦药物碱厂有限公司; 山东威智百科药业有限公司 |
| 2024/11/01Generic · Class 3 | 劳拉西泮片CYHS2403722 | 北京益民药业有限公司 |
| 2024/11/01Generic · Class 3 | 黄体酮注射液CYHS2403721 | 重庆万霖生物医药科技有限公司; 河南科伦药业有限公司 |
72 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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